Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT01489111) enrolled 36 people, all of whom received the investigational treatment turoctocog alfa pegol (also called N8-GP), a clotting factor product being studied in people with haemophilia A (a condition where the blood does not clot properly). Thirty-five of the 36 participants completed the study, and one did not. The trial was measuring how well the treatment controlled bleeding during and after surgery, using a four-point rating scale: "excellent," "good," "moderate," or "none." The reported data shows that, for the primary outcome — bleeding control rated by the surgeon right at the end of the operation — out of 49 surgeries assessed, 25 were rated "excellent," 22 were rated "good," 2 were rated "moderate," and none were rated "none." For the days immediately after surgery (days 1–6), the reported data shows 0 bleeding episodes rated "excellent," 1 rated "good," 0 rated "moderate," and 0 rated "none," with 1 episode where the rating data was not fully specified in the structured results. For the later post-operative period (days 7–14), the reported data shows 1 episode rated "excellent," 1 rated "good," and none rated "moderate" or "none." The average amount of the treatment used during surgery was reported as 20.7 IU/kg (a measure of dose per kilogram of body weight), and 33.0 IU/kg across days 1–6 after surgery. The reported data also shows that zero participants developed antibodies (called inhibitors) against the clotting factor during the trial — inhibitors are proteins the body can sometimes produce that may reduce a treatment's ability to work. No comparison group was included in this trial, so all results reflect a single group of participants receiving the one treatment. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 32293786) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 3 Haemophilia Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have agreed to take part and given your consent before any trial-related activities begin
- You are currently taking part in the pathfinder™2 or pathfinder™4 trial and have already received at least 5 doses of the study drug called N8-GP
- You are scheduled for a major surgery that will need daily checks of your clotting factor levels and wound healing for at least 3 days
- You (and/or your legal guardian or representative) are able to recognise a bleeding episode, use an electronic diary, treat bleeds at home, and follow the trial's instructions
Who may not be able to join:
- You have a known or suspected allergy to the trial drug, including an allergy to hamster protein or similar products
- You previously left the pathfinder™2 or pathfinder™4 trial after receiving the study drug (unless you only paused to join this specific trial)
- You have taken part in another clinical trial involving a different investigational drug within the last 30 days (or within the last year if you are in Brazil, unless there is a direct benefit to you)
- Your blood tests at screening show a certain type of antibody (called an inhibitor) that works against the clotting factor, at a level of 0.6 BU/mL or higher
- You have a history of arterial blood clots such as a heart attack or brain clot, or have previously had a deep vein thrombosis or a blood clot in the lungs
- You are currently taking medications that affect the immune system or chemotherapy drugs
- You have any other illness or condition (including liver disease, kidney disease, inflammatory conditions, or mental health disorders) that the trial doctor believes could put you at risk or affect your participation (confirm with trial site)
- There are any language difficulties, personal reasons, or other barriers that would prevent you from fully understanding or cooperating with the trial
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Global Clinical Registry (GCR, 1452), Novo Nordisk A/S
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
3 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Haemostatic Effect During Surgery Evaluated by the Four-point Scale, Assessed by the Investigator/Surgeon at the Day of Surgery - Four-point Response Scale: Excellent, Good, Moderate or None
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.